MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 11/03/2016

Event Type  malfunction  

Event Description

It was reported that the programming tablet was dropped and subsequently the screen was cracked and the tablet wasn¿t charging properly.A replacement tablet was provided to the medical professional.The suspect tablet has not been received to date.No additional relevant information has been received to date.

Manufacturer Narrative

(b)(4).

Event Description

The suspect tablet was received and underwent product analysis.Upon receipt it was noted that the tablet's main battery had a remaining charge of 92% and the tablet's display was cracked.The ac power adapter was not received with the tablet and therefore analysis could not be performed on this component.A known good sd card was inserted into the tablet and the vns software booted normally.A virus scan found no anomalies.The tablet was then connected to a known good ac power adapter and allowed to charge fully.The tablet was then left powered on for more than an hour while a series of interrogations and diagnostic testing were performed using the tablet.No anomalies were observed during this testing.At the end of the testing it was noted that 85% of the battery charge remained.Analysis was unable to duplicate the report that the tablet would not hold a charge.However an ac power adapter was not received with the tablet.Therefore analysis could not determine if the ac power adapter contributed to the reported charging issues with the tablet.

• Brand Name: PROGRAMMING COMPUTER
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6210378
• MDR Text Key: 63424001
• Report Number: 1644487-2016-02953
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1